510(k) · Cleared
ClearedCardiq Express Version 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 26, 2008 as substantially equivalent to K041267 (General Electric Medical Systems, 2004) after a 111-day review. Its family tree reaches back 3 generations to 2000. 32 later devices descend from it.
- Decided
- Feb 26, 2008
- Review
- 111 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000315 (2000). 5 ancestors in all. 32 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
- 2 generations backK013422 Cardiq FunctionGE Medical Systems · 2001
- 1 generation backK041267 Cardiq Analysis IiiGeneral Electric Medical Systems · 2004
- This deviceK073138 Cardiq Express Version 2.0GE Medical Systems · 2008
- Descendant · cites it directly · 25 of its ownK110366 Syngo.CT Cardiac FunctionSiemens AG · 2011 · Recalled
- Descendant · 2 generations on · 14 of its ownK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- Descendant · 3 generations on · 11 of its ownK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · 4 generations on · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · 5 generations on · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K110366Syngo.CT Cardiac FunctionSiemens AG · 2011 · cites it directly25descendants
- K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on14descendants
- K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019 · 3 generations on11descendants
- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · 4 generations on9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000315 | Ventricular Analysis Toolkit Option | GE Medical Systems | 2000 | — |
| −2 | K013422 | Cardiq Function | GE Medical Systems | 2001 | — |
| −1 | K041267 | Cardiq Analysis Iii | General Electric Medical Systems | 2004 | — |
| 0 (this device) | K073138 | Cardiq Express Version 2.0 | GE Medical Systems | 2008 | — |
| +1 | K110366 | Syngo.CT Cardiac Function | Siemens AG | 2011 | 1 |
| +2 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +3 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +4 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +5 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041267 | Cardiq Analysis IiiSummary page 1…to the predicate device listed below: Device Name IFDA Ctearance GE CardIQ Analysis III IK041 267 4. Device Description The GE Medical Systems CardIQ Xpress 2.0 software is a post processing software option for the Adva… | 2004 |
What descends from it? (32)
See all 326 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110366 (Siemens AG, 2011) has gone furthest, with 25 descendants of its own.
- 6 other devices also cite its predicate K041267.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
CardIQ Xpress 2.0 is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardlQ Xpress 2.0 is a CT, non-invasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for…
Read the full statement (263 words)
CardIQ Xpress 2.0 is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
CardlQ Xpress 2.0 is a CT, non-invasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardlQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardlQ Xpress 2.0 the user can color code the myocardial tissue to show hypo/hyper-dense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to align the heart. The IVUS-like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added.
CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073138: Cardiq Express Version 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073138
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026